Division of Medical Oncology, Department of Internal Medicine, The Ohio State University, Columbus, OH, United States; The Ohio State University Comprehensive Cancer Center, James Cancer Hospital, & Solove Research Institute, Columbus, OH, United States.
The Ohio State University Comprehensive Cancer Center, James Cancer Hospital, & Solove Research Institute, Columbus, OH, United States.
J Geriatr Oncol. 2024 Sep;15(7):101844. doi: 10.1016/j.jgo.2024.101844. Epub 2024 Aug 22.
Novel supportive care interventions designed for an aging population with lung cancer are urgently needed. We aimed to determine the feasibility of a novel supportive care physical therapy (PT) plus progressive muscle relaxation (PMR) intervention delivered to older adults with advanced lung cancer in the United States (US).
This clinical trial, Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT: NCT04229381), recruited adults aged ≥60 years with unresectable stage III/IV non-small cell (NSCLC) or small cell lung cancer (SCLC) receiving cancer treatment at The James Thoracic Oncology Center (planned enrollment, N = 20). There were no exclusion criteria pertaining to performance status, laboratory values, prior cancer diagnoses, comorbidities, or brain metastases. Participants were evaluated by PT and psychology and given an exercise pedaler, resistance bands, a relaxation voice recording, and instructions at study initiation. Participants were evaluated in-person by PTs and psychologists at the start and end of the 12-session intervention, with the intervening sessions conducted via virtual health. Participants completed self-reported measures of functional status, symptoms, and mood longitudinally with the following instruments: EQ-5D-5L, Patient Health Questionnaire-9, and General Anxiety Disorder-7. PT assessments included the Short Physical Performance Battery (SPPB) and the two-minute walk test. Feasibility was defined as at least 60% of participants completing at least 70% of all intervention sessions. Optional gut microbiome samples and activity monitoring data (ActiGraph®) were also collected.
The ROAR-LCT study concluded after consenting 22 patients. Among the 22 consented, 18 (81.8%) started the intervention; 11 participants (61.1%) completed at least 70% of all study sessions. All participants with SCLC completed the intervention. Reasons for withdrawal included progression of disease or hospitalization. The majority (88.9%) of patients who started were able to complete at least one virtual health session. Participants' functional status, SPPB, depression, and anxiety scores were stable from pre- to post-intervention. Participants who withdrew had worse baseline scores across domains. Seven microbiome and six ActiGraph® samples were collected.
This is one of the first PT + PMR supportive care interventions using virtual health among older adults with advanced lung cancer to achieve feasibility in the US.
专为患有肺癌的老年人群设计的新型支持性护理干预措施亟待开发。我们旨在确定为美国(美国)老年晚期肺癌患者提供新型支持性护理物理治疗(PT)加渐进性肌肉放松(PMR)干预的可行性。
这项临床试验,Resiliency Among Older Adults Receiving Lung Cancer Treatment(ROAR-LCT:NCT04229381),招募了年龄在 60 岁以上、接受癌症治疗的不可切除 III/IV 期非小细胞(NSCLC)或小细胞肺癌(SCLC)患者。无活动状态、实验室值、既往癌症诊断、合并症或脑转移等排除标准。研究开始时,患者由 PT 和心理学家进行评估,并提供脚踏车、阻力带、放松语音记录和说明。在干预的 12 个疗程中,PT 和心理学家通过虚拟健康定期对患者进行评估,其余疗程通过虚拟健康进行。患者使用以下仪器进行功能状态、症状和情绪的纵向自我报告测量:EQ-5D-5L、患者健康问卷-9 和广泛性焦虑症-7。PT 评估包括简短体能表现电池(SPPB)和两分钟步行测试。可行性定义为至少 60%的患者完成至少 70%的所有干预课程。还收集了可选的肠道微生物组样本和活动监测数据(ActiGraph®)。
ROAR-LCT 研究在同意 22 名患者后结束。在 22 名同意的患者中,有 18 名(81.8%)开始接受干预;11 名参与者(61.1%)完成了至少 70%的所有研究课程。所有 SCLC 患者均完成了干预。退出的原因包括疾病进展或住院治疗。大多数(88.9%)开始治疗的患者能够完成至少一次虚拟健康治疗。患者的功能状态、SPPB、抑郁和焦虑评分在干预前后保持稳定。退出的患者在所有领域的基线评分都较差。收集了 7 个微生物组和 6 个 ActiGraph®样本。
这是美国首例使用虚拟健康为老年晚期肺癌患者提供 PT+PMR 支持性护理干预的研究之一,达到了可行性。